A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation

Breast Cancer Clinical Trial

Official title: A Randomized, Open-label Study of High-Dose Vitamin D Versus Standard of Care Vitamin D Supplementation to Evaluate the Impact on Bone Health in Young Women With Early Stage Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.

Clinical Trial Description

This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy. ;

Related Conditions & MeSH terms

• Breast
• Breast Cancer
• Breast Neoplasms
• Osteoporosis

• NCT number: NCT05016310
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2021
• Completion date: December 2024